esophagectomy in treating patients with high-grade dysplasia of the esophagus or stage i, stage ii, or stage iii esophageal cancer

Conditions: Esophageal Cancer

Summary: rationale: laparoscopic-assisted surgery and video-assisted thoracoscopy are less invasive types of surgery for esophageal cancer that may have fewer side effects and improve recovery. purpose: this phase ii trial is studying how well laparoscopic-assisted surgery and video-assisted thoracoscopy work in treating patients who are undergoing esophagectomy for high-grade dysplasia of the esophagus or stage i, stage ii, or stage iii esophageal cancer.

objectives: * determine the feasibility of performing minimally invasive esophagectomy (mie), in terms of 30-day mortality, in patients with high-grade dysplasia of the esophagus or stage i-iii esophageal cancer. * determine the complications associated with this procedure in these patients. * determine the rate at which conversion to open operation is required in patients undergoing this procedure. * determine the length of the operation, duration of intensive care unit stay, and length of hospital stay in patients undergoing this procedure. * determine feasibility and conversion rate of mie after neoadjuvant therapy. * assess the effectiveness of lymph node dissection by mie by recording the total number of lymph nodes dissected. * assess outcomes at follow-up to three years. outline: this is a multicenter study. patients undergo minimally invasive esophagectomy comprising video-assisted thoracoscopy to mobilize the thoracic esophagus in combination with laparoscopy to complete the esophagectomy and a neck incision to mobilize the cervical esophagus. mortality at 30 days is assessed. patients are followed every 3 months for 2 years and then every 6 months for 1 year. actual accrual: a total of 110 patients were accrued for this study.

Eligibility criteria:
inclusion criteria: disease characteristics: * high grade dysplasia of the esophagus who would undergo esophagectomy or esophageal cancer at stage t1-t3, n0-n1 who require esophagectomy (patients with m1 disease and/or bulky lymph node involvement were excluded). * pathological confirmation of a diagnosis of cancer or high-grade dysplasia of the esophagus by biopsy. * computerized tomography (ct) scan of chest and abdomen within 6 weeks prior to registration * stomach must be available for conduit * age of 18 and over * ecog performance status of 0-2 * creatinine less than 2 mg/dl * patients with esophageal cancer who would be treated with neoadjuvant chemotherapy and/or radiation were eligible. if patients were registered prior to receiving neoadjuvant chemotherapy they were allowed up to 5 months to complete therapy and any restaging that was necessary before operation was performed. * the patient was considered an appropriate candidate for surgery based on preoperative clinical staging and physiological factors prior to registration as documented in the surgical plan. pre-operative staging should include: * endoscopic ultrasound (eus) * positron emission tomography (pet) scan and/or laparoscopic staging (laparoscopic staging could be performed on the day of resection. additional evaluation was recommended if the pet scan suggested distant metastatic disease.) exclusion criteria: * cancer extending into the stomach more than 20% * prior anti-reflux or gastric operations * prior right thoracotomy * prior major neck operation other than the removal of superficial skin lesion

Keywords: esophageal cancer minimally invasive esophagectomy (mie)